Pain, ChronicNCT03789227
CT-guided Ablation of the Ganglion Impar for Pelvic Tumors: Comparethe Addition of Ketorolac or Dexamethasone
A study testing ganglion impar block in people with Pain, Chronic, run by Mansoura University at 1 site in Egypt.
Trial summary
this study investigator will resaearsh about the efficacy of addition of ketorlac or dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier efficacy in increasing the intensity or the duration of the block Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- ganglion impar block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of either sex aged between 20 to 70 years old with pelvic tumor
Who cannot join
- Patient's refusal.
- Sever Hepatic and renal impairment.
- History of allergy to the used drugs.
- Infection at the area of injection.
- Coagulopathies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university , oncology mansoura university center
Al Mansurah, Dakahlia Governorate
About this study
Official title: CT-guided Ethyl Alcohol Ablation of the Ganglion Impar for Pelvic Tumors: Does the Addition of Ketorolac or Dexamethasone Makes a Difference?
this study investigator will resaearsh about the efficacy of addition of ketorlac or dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier efficacy in increasing the intensity or the duration of the block
Read the detailed description
The aim of this study is to compare the effect of administration of ketorolac versus dexamethasone on CT guided ganglion impar block with ethyl alcohol in patients with pelvic tumor.
The primary outcome will be the onset of sensory block, patient satisfaction measured by patient satisfaction score ( Jones KD, Sutton C., 2003), intensity of pain measured by a linear visual analogue scale (VAS) (Bourdel, N. et al., 2014) and incidence of early complications and side effects.
The secondary outcome will include the duration of sensory block, the time and the amount of post-procedure analgesic requirement, itching and any associated complications.
We hypothesized that CT guided ganglion impar block will be a good choice in pain reduction in patients with chronic pelvic pain. Pain reduction will be greater in dexamethasone and ketorolac group compared to alcohol group.Preinterventional assessment includes general, pain specific history taking (location, quality, intensity, relieving and provoking incidences) and pain in specific physical examination (inspection and palpation) will be carried out. Type of pelvic tumor, investigation related to tumor, previous operations, chemotherapy, basic demographic variables including age, sex and body mass index will be recorded. Routine investigations include bleeding profiles (bleeding time, clotting time, INR), blood picture, liver and kidney function tests will be carried out. A linear visual analogue scale (VAS) on a scale of 0-10 mm (where 0 for no pain and 10 for worst pain) will be explained to each patient. Written informed consent will be obtained, detailed information on risks and complications will be provided.The vital signs (heart rate, blood pressure, spo2) will be recorded. After establishing an access to peripheral venous line, 500 ml normal saline will be given to the patient, the patient will be in the prone position with a pillow under the abdomen to allow flexion of the lumbo-sacral spine with internal rotation of the lower extremities.All patients will be asked to empty the bladder and rectum before the start of the procedure to facilitate needle placement and avoid inadvertent injection. The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. A needle localizer will be placed on the skin surface to identify and mark the sacro-coccygeal disc.
Sterilization of The patient's sacral and gluteal areas will be provided with povidone iodine antiseptic solution and this area was circumferentially draped with sterile towels. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. The patient will be rescanned to confirm the position of the tip of the spinal needle at the anterior aspect of the sacro-coccygeal junction in the retroperitoneal space (Datir A and Connell D., 2010).
Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95% ± 8 mg dexamethasone or (15 mg ketorolac) will be slowly injected for therapeutic chemical neurolysis.
- Conditions
- Pain, Chronic
- Being tested
- ganglion impar block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganglion impar blockProcedure or surgery
the patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml. Receives: Procedure: ganglion impar block |
| Group D | Active comparator | ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml. Receives: Procedure: ganglion impar block |
| Group K | Active comparator | ganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml. Receives: Procedure: ganglion impar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the onset of sensory block
occurance of analgesia
Measured: one week
patient satisfaction
patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100
Measured: 6 month
intensity of pain
visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst
Measured: 6 month
incidence of early complications
Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication
Measured: 6 month
Secondary outcomes (1)
the time and the amount of post-procedure analgesic requirement
the amount and timing of analgesic consumption and types of analgesics
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek M. Shams, MD, Study director, : Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789227
- Sponsor's protocol ID
- - MFM-IRB ,MD ∕ 16.06.45
- Status last verified
- Sep 2020
- First submitted
- 26 Dec 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Ethyl Alcohol Ablation of the Ganglion Impar for Pelvic Tumors: Does the Addition of Ketorolac or Dexamethasone Makes a Difference?
- ClinicalTrials.gov ID
- NCT03789227
- Acronym / sponsor ID
- - MFM-IRB ,MD ∕ 16.06.45
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study investigator will resaearsh about the efficacy of addition of ketorlac or dexamethasone to alcohol in ablation of ganglion impar in pelvic tumour to asses thier efficacy in increasing the intensity or the duration of the block
Detailed description
The aim of this study is to compare the effect of administration of ketorolac versus dexamethasone on CT guided ganglion impar block with ethyl alcohol in patients with pelvic tumor.
The primary outcome will be the onset of sensory block, patient satisfaction measured by patient satisfaction score ( Jones KD, Sutton C., 2003), intensity of pain measured by a linear visual analogue scale (VAS) (Bourdel, N. et al., 2014) and incidence of early complications and side effects.
The secondary outcome will include the duration of sensory block, the time and the amount of post-procedure analgesic requirement, itching and any associated complications.
We hypothesized that CT guided ganglion impar block will be a good choice in pain reduction in patients with chronic pelvic pain. Pain reduction will be greater in dexamethasone and ketorolac group compared to alcohol group.Preinterventional assessment includes general, pain specific history taking (location, quality, intensity, relieving and provoking incidences) and pain in specific physical examination (inspection and palpation) will be carried out. Type of pelvic tumor, investigation related to tumor, previous operations, chemotherapy, basic demographic variables including age, sex and body mass index will be recorded. Routine investigations include bleeding profiles (bleeding time, clotting time, INR), blood picture, liver and kidney function tests will be carried out. A linear visual analogue scale (VAS) on a scale of 0-10 mm (where 0 for no pain and 10 for worst pain) will be explained to each patient. Written informed consent will be obtained, detailed information on risks and complications will be provided.The vital signs (heart rate, blood pressure, spo2) will be recorded. After establishing an access to peripheral venous line, 500 ml normal saline will be given to the patient, the patient will be in the prone position with a pillow under the abdomen to allow flexion of the lumbo-sacral spine with internal rotation of the lower extremities.All patients will be asked to empty the bladder and rectum before the start of the procedure to facilitate needle placement and avoid inadvertent injection. The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. A needle localizer will be placed on the skin surface to identify and mark the sacro-coccygeal disc.
Sterilization of The patient's sacral and gluteal areas will be provided with povidone iodine antiseptic solution and this area was circumferentially draped with sterile towels. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. The patient will be rescanned to confirm the position of the tip of the spinal needle at the anterior aspect of the sacro-coccygeal junction in the retroperitoneal space (Datir A and Connell D., 2010).
Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95% ± 8 mg dexamethasone or (15 mg ketorolac) will be slowly injected for therapeutic chemical neurolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Procedure: ganglion impar blockganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 4 ml saline in a total volume 12 ml. |
| Group D | Active comparator | Procedure: ganglion impar blockganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 8 mg dexamethasone with 4 ml saline in a total volume 12 ml. |
| Group K | Active comparator | Procedure: ganglion impar blockganglion impar block :patients will receive a premixed solution of 3 ml lidocaine 2%, 5 ml absolute alcohol 95% and 15 mg ketorolac with 4 ml saline in total volume 12 ml. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients of either sex aged between 20 to 70 years old with pelvic tumor
Key exclusion criteria (5 listed)
- Patient's refusal.
- Sever Hepatic and renal impairment.
- History of allergy to the used drugs.
- Infection at the area of injection.
- Coagulopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ganglion impar blockthe patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%. | Procedure or surgery | Group C, Group D, Group K |
Primary outcome
the onset of sensory block
Time frame: one week
occurance of analgesia
patient satisfaction
Time frame: 6 month
patient satisfaction score ( Jones KD, Sutton C., 2003) by questionnaire for 100
intensity of pain
Time frame: 6 month
visual analogue scale (VAS) scale from 0 to 10 o no pain 10 maximum pain 0 better 10 worst
incidence of early complications
Time frame: 6 month
Early complications will be recorded including allergy, bleeding, hematoma, infection, perforation of the rectum and/or bowel, bladder incontinence and nerve root injury. The cauda equine syndrome is another potential complication
1 secondary outcome
the time and the amount of post-procedure analgesic requirement
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M. Shams, MD study director
: Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ganglion impar block in people with Pain, Chronic, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the onset of sensory block (time frame: one week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.